Name: Predicase
Price: 199 USD

K-number	K853067
Device name	FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT
Applicant	Idt, A Division of Whittaker M.A. Bioproducts
Product code	GRE
Device class	Class I
Decision date	Oct 22, 1985
Decision	Substantially Equivalent
Regulation	866.3520

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Source

View the full FDA submission: accessdata.fda.gov

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FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT

Everything you need for a 510(k) submission. Nothing you don't.